SYSTEMS AND METHODS FOR AUTOMATED TRACKING AND OPTIMIZATION OF GLOBAL MANUFACTURING AND SUPPLY BASED ON IMPACTS OF POST-APPROVAL CHANGES

A computing device-implemented method for automated tracking and optimization of global manufacturing and supply based on impacts of post-approval changes (PACs) is discussed. An exemplary method includes retrieving data from data sources including at least an inventory database, a regulatory databa...

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Bibliographische Detailangaben
Hauptverfasser:	Bornstein, Clare Elizabeth, McDonald, Kevin, Markely, Lam Raga Anggara
Format:	Patent
Sprache:	eng
Schlagworte:	CALCULATING COMPUTER SYSTEMS BASED ON SPECIFIC COMPUTATIONAL MODELS COMPUTING COUNTING DATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FORADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORYOR FORECASTING PURPOSES ELECTRIC DIGITAL DATA PROCESSING HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATIONTECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING ORPROCESSING OF MEDICAL OR HEALTHCARE DATA INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTEDFOR SPECIFIC APPLICATION FIELDS PHYSICS SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE,COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTINGPURPOSES, NOT OTHERWISE PROVIDED FOR
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Zusammenfassung:	A computing device-implemented method for automated tracking and optimization of global manufacturing and supply based on impacts of post-approval changes (PACs) is discussed. An exemplary method includes retrieving data from data sources including at least an inventory database, a regulatory database, and a PAC information database. The method further includes analyzing the retrieved data to identify one or more impacts of at least one PAC on one or more drug products or drug substances using a predefined ruleset for determining which changes were implemented for each lot. The method also includes generating a list of the identified one or more impacts on the one or more drug products or drug substances.